Surveillance Study of NovoRapid® for New Drug Re-examination

Regulatory Post Marketing Surveillance Study of NovoRapid for New Drug Re-examination

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01490112

Enrollment

1239

Registered

2011-12-12

Start date

2005-01-31

Completion date

2006-06-30

Last updated

2016-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2

Brief summary

This study is conducted in Asia. The aim of this study is to observe the safety and efficacy of insulin aspart (NovoRapid®) administered via vial and three different devices.

Interventions

DRUGinsulin aspart

Subjects who had a first drug date on NovoRapid® were prescribed to inject insulin aspart using vial, FlexPen, NovoLet or Penfill devices. Injected subcutaneously (s.c., under the skin) immediately before meals for 24 weeks

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* Subjects with diabetes mellitus (type 1, type 2, or gestational) prescribed with insulin aspart (NovoRapid®)

Design outcomes

Primary

Measure	Time frame
Change in weight	—

Secondary

Measure	Time frame
Fasting blood glucose (FBG)	—
HbA1c (glycosylated haemoglobin)	—
Adverse events: Serious and non-serious	—

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026